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PROSTATE CANCER

First point-of-care PSA test for prostate cancer detection

The FDA’s approval of the first point-of-care total PSA test for prostate cancer has the potential to improve patient care by streamlining PSA testing. However, a Clinical Laboratory Improvement Amendments waiver is needed before this test can be fully integrated into clinical care.

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Fig. 1: A microfluidic-based immunoassay employing Sangia technology.

References

  1. U.S. Food and Drug Administration. Recently-approved devices: Sangia Total PSA Test - P170037. FDA https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm630197.htm (updated 31 Jan 2019).

  2. U.S. Food and Drug Administration. Summary of safety and effectiveness data (SSED). FDA https://www.accessdata.fda.gov/cdrh_docs/pdf17/p170037b.pdf (2019).

  3. OPKO Diagnostics. Instructions for use. FDA https://www.accessdata.fda.gov/cdrh_docs/pdf17/p170037c.pdf (2019).

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Correspondence to Michael A. Gorin.

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Meyer, A.R., Gorin, M.A. First point-of-care PSA test for prostate cancer detection. Nat Rev Urol 16, 331–332 (2019). https://doi.org/10.1038/s41585-019-0179-1

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